U.S. patent application number 11/790124 was filed with the patent office on 2008-06-12 for composite endoluminal prostheses for treating vulnerable plaque.
Invention is credited to Patricia Scheller.
Application Number | 20080140182 11/790124 |
Document ID | / |
Family ID | 39499207 |
Filed Date | 2008-06-12 |
United States Patent
Application |
20080140182 |
Kind Code |
A1 |
Scheller; Patricia |
June 12, 2008 |
Composite endoluminal prostheses for treating vulnerable plaque
Abstract
The invention provides expandable tubular endoluminal prostheses
for the treatment of atherosclerotic lesions, such as vulnerable
plaques, and methods for treating such lesions using the
prostheses. The endoprostheses may include at least two expandable
ring-like elements disposed on the inside or about the outer
surface of an at least substantially tubular biodegradable element.
The ring-like elements may be radio-opaque and may have a sinuate
form. In use, a prosthesis according to the invention is expanded
in a blood vessel so that the tubular biodegradable element at
least partially covers an atherosclerotic lesion, such as a
vulnerable plaque.
Inventors: |
Scheller; Patricia;
(Solebury, PA) |
Correspondence
Address: |
PATTON BOGGS LLP
8484 WESTPARK DRIVE, SUITE 900
MCLEAN
VA
22102
US
|
Family ID: |
39499207 |
Appl. No.: |
11/790124 |
Filed: |
April 24, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60795576 |
Apr 28, 2006 |
|
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Current U.S.
Class: |
623/1.17 ;
623/1.15; 623/1.16 |
Current CPC
Class: |
A61F 2/89 20130101; A61F
2002/075 20130101; A61F 2/07 20130101; A61F 2210/0004 20130101 |
Class at
Publication: |
623/1.17 ;
623/1.15; 623/1.16 |
International
Class: |
A61F 2/06 20060101
A61F002/06 |
Claims
1. An expandable endovascular prosthesis, comprising: at least two
expandable annular elements, each having a central axis; and an at
least substantially tubular biodegradable element having an inner
surface, an outer surface and a longitudinal central axis, wherein
the central axis of each of the expandable annular elements and of
the tubular biodegradable element are at least substantially
aligned.
2. The prosthesis of claim 1, wherein the expandable annular
elements are at least substantially sinuate in form.
3. The prosthesis of claim 1, wherein at least two of the
expandable annular elements are disposed within the tubular
biodegradable element.
4. The prosthesis of claim 1, wherein at least two of the
expandable annular elements are disposed about the outer surface of
the tubular biodegradable element.
5. The prosthesis of claim 1, wherein the at least two expandable
annular elements are affixed to the tubular biodegradable
element.
6. The prosthesis of claim 1, wherein at least one of the
expandable annular elements is at least partially radio-opaque.
7. The prosthesis of claim 1, wherein at least one of the
expandable annular elements is at least partially metallic.
8. The prosthesis of claim 1, wherein the prosthesis is at least
partially balloon expandable.
9. The prosthesis of claim 1, wherein the at least two expandable
annular elements are a least partially self-expanding.
10. The prosthesis of claim 1, wherein of the at least two
expandable annular elements, one is disposed at or near one end of
the tubular biodegradable element and another is disposed at or
near the opposite end of the tubular biodegradable element.
11. The prosthesis of claim 1, wherein the tubular biodegradable
element is at least partially porous.
12. The prosthesis of claim 1, wherein the tubular biodegradable
element has pores having diameters at least predominantly less than
500 microns.
13. The prosthesis of claim 1, wherein the tubular biodegradable
element has pores having diameters at least predominantly in the
range of 20 to 200 microns.
14. The prosthesis of claim 1, wherein the expandable annular
elements are at least substantially non-biodegradable.
15. The prosthesis of claim 1, wherein the expandable annular
elements are biodegradable at a slower rate than the tubular
biodegradable element.
16. The prosthesis of claim 1, wherein at least some of the
expandable annular elements consists essentially of
non-biodegradable metallic material.
17. The method of claim 16, wherein the tubular biodegradable
element is at least substantially polymeric.
18. The prosthesis of claim 1, wherein neighboring annular elements
are not connected to each other by connective elements.
19. The prosthesis of claim 1, wherein at least two neighboring
annular elements are connected by at least one connective
element.
20. The prosthesis of claim 1, wherein neighboring annular elements
are connected by at least one connective element.
21. A method for treating vulnerable plaque in a patient in need
thereof, comprising the steps of: deploying a prosthesis according
to claim 1 at a site of a vulnerable plaque in blood vessel of a
patient.
22. The method of 21, further comprising the step of delivering the
prosthesis to the site using a delivery catheter.
23. The method of claim 21, further comprising the step of: prior
to deploying the endoprosthesis, locating the site of the
vulnerable plaque.
24. The method of claim 21, wherein at least two of the expandable
annular elements of the prosthesis are disposed within the tubular
biodegradable element.
25. The method of claim 21, wherein at least two of the expandable
annular elements of the prosthesis are disposed about the outer
surface of the tubular biodegradable element.
26. The method of claim 21, wherein the at least two expandable
annular elements of the prosthesis are affixed to the tubular
biodegradable element.
27. The method of claim 21, wherein at least one of the expandable
annular elements of the prosthesis is at least partially
radio-opaque.
28. The method of claim 21, wherein at least one of the expandable
annular elements of the prosthesis is at least partially
metallic.
29. The method of claim 21, wherein the prosthesis is at least
partially balloon expandable.
30. The method of claim 21, wherein the at least two expandable
annular elements of the prosthesis are a least partially
self-expanding.
31. The method of claim 21, wherein of the at least two expandable
annular elements of the prosthesis, one is disposed at or near one
end of the tubular biodegradable element and another is disposed at
or near the opposite end of the tubular biodegradable element.
32. The method of claim 21, wherein the tubular biodegradable
element of the prosthesis is at least partially porous.
33. The method of claim 21, wherein the tubular biodegradable
element of the prosthesis has pores having diameters at least
predominantly less than 500 microns.
34. The method of claim 21, wherein the tubular biodegradable of
the prosthesis has pores having diameters at least predominantly in
the range of 20 to 200 microns.
35. An expandable endovascular prosthesis, comprising: at least two
expandable non-biodegradable metallic annular elements, each having
a central axis; and an at least substantially tubular biodegradable
polymeric element having a wall and a longitudinal central axis,
wherein the wall is porous forming pores at least predominantly 500
microns or less in diameter, wherein the central axis of each of
the expandable annular elements and of the tubular biodegradable
element are at least substantially aligned.
36. The prosthesis of claim 35, wherein neighboring annular
elements are not connected to each other by connective
elements.
37. The prosthesis of claim 35, wherein at least two neighboring
annular elements are connected by at least one connective
element.
38. The prosthesis of claim 37, wherein neighboring annular
elements are connected by at least one connective element.
Description
[0001] This application claims the benefit of U.S. provisional
patent application Ser. No. 60/795,576 filed Apr. 28, 2006, which
is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The invention relates generally to the fields of expandable
endoluminal vascular prostheses and their use in treating
atherosclerotic lesions. BACKGROUND OF INVENTION
[0003] Vulnerable plaques, which are sometimes referred to as
high-risk atherosclerotic plaques, are arterial atherosclerotic
lesions characterized by a subluminal thrombotic lipid-rich pool of
materials contained by a thin fibrous cap. Although vulnerable
plaques are non-stenotic or nominally stenotic, it is believed that
their rupture, resulting in the release of thrombotic contents,
accounts for a significant fraction of adverse cardiac events.
[0004] U.S. Publication No. 2002/0004679 discloses drug eluting
polymer stents for treating restenosis with topoisomerase
inhibitors, and is incorporated herein by reference in its
entirety.
[0005] U.S. Publication No. 2003/0009213 discloses stents having a
drug-eluting cover for the treatment of vulnerable plaque and
manners of affixing the cover to the stent, and is incorporated
herein by reference in its entirety.
[0006] U.S. Publication No. 2003/0125799 discloses intravascular
stents for the treatment of vulnerable plaque that consist of
opposing end ring portions and a central strut portion having a
zig-zag configuration that connects with the end portion at apices
of the zig-zag structure, and is incorporated herein by reference
in its entirety. The particular zig-zag structure of the stent
tends to cause substantial foreshortening upon radial expansion of
the device.
[0007] U.S. Publication No. 2005/0038503 discloses various
filament-based endovascular prostheses, and is hereby incorporated
by reference herein in its entirety.
[0008] U.S. Publication No. 2005/0137678 discloses a low-profile
resorbable polymer stent and compositions therefore, and is
incorporated herein by reference in its entirety.
[0009] U.S. Publication No. 2005/0228473 discloses frame-like
devices for delivering treatments to sites within arteries, and is
hereby incorporated by reference herein in its entirety.
[0010] U.S. Publication No. 2005/0287184 discloses drug-delivery
stent formulations for treating restenosis and vulnerable plaque,
and is hereby incorporated by reference herein in its entirety.
SUMMARY OF INVENTION
[0011] The present invention provides tubular endoluminal
prostheses and methods of use thereof for treating atherosclerotic
lesions such as vulnerable plaques.
[0012] One embodiment of the invention provides an expandable
endovascular prosthesis for the treatment of vulnerable plaques
that includes at least two expandable annular elements (ring-like),
each having a central axis; and an at least substantially tubular
biodegradable element having an inner surface, an outer surface and
a longitudinal central axis. The central axis of each of the
sinuate annular elements and of the tubular biodegradable element
are aligned so that the composite device has a tubular profile. At
least one of the expandable annular elements may be at least
substantially sinuate in form. At least some of the expandable
annular elements may be at least partially radiopaque to facilitate
proper placement of the prosthesis within a blood vessel.
[0013] A further embodiment of the invention provides a method for
treating vulnerable plaque in a patient in need thereof that
includes the step of: deploying an endoprosthesis according to the
invention at a site of a vulnerable plaque in a blood vessel of a
patient. The biodegradable element of the prosthesis may be
drug-eluting or not drug-eluting.
[0014] Additional features, advantages, and embodiments of the
invention may be set forth or apparent from consideration of the
following detailed description, drawings, and claims. Moreover, it
is to be understood that both the foregoing summary of the
invention and the following detailed description are exemplary and
intended to provide further explanation without limiting the scope
of the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 illustrates an embodiment of a prosthesis according
to the invention which has four sinuate annular segments covered by
a biodegradable tubular element.
[0016] FIG. 2 shows a "rolled out" view of the prosthesis shown in
FIG. 1.
DETAILED DESCRIPTION
[0017] The invention provides tubular endovascular prostheses for
the treatment of vulnerable plaque and methods of treatment using
the endoprostheses.
[0018] One embodiment of the invention provides an expandable
endovascular prosthesis for the treatment of vulnerable plaques
that includes: at least two expandable annular elements, each
having a central axis; and an at least substantially tubular
biodegradable element having an inner surface, an outer surface and
a longitudinal central axis. The central axis of each of the
sinuate annular elements and of the biodegradable tubular element
are aligned so that the prosthesis as a whole has an at least
substantially tubular form. One or more of the expandable annular
elements may be at least substantially tubular or ring-like in
form. The at least two expandable annular elements may be fixed or
connected to the tubular biodegradable element. In one variation,
of the at least two expandable annular elements, one is disposed at
or near one end of the tubular biodegradable element and another is
disposed at or near the opposite end of the tubular biodegradable
element. In another variation, there are only two expandable
annular elements, one at or near each end of the tubular
biodegradable element. In still another variation, there are three
expandable annular elements, with one being located one at or near
each of the ends of the tubular biodegradable element
[0019] In one variation, the biodegradable tubular element is
disposed within the expandable annular elements. In another
variation, at least two of the expandable annular elements surround
the biodegradable tubular element.
[0020] In another variation, the expandable annular elements are
disposed within the biodegradable tubular element. In another
variation, at least two of the expandable annular elements are
disposed within the lumen of the biodegradable tubular element.
[0021] One or more of the expandable annular elements may be at
least partially radio-opaque. One or more of the expandable annular
elements may be at least partially metallic. The biodegradable
tubular element may be less radio-opaque than the at least
partially expandable annular elements. The biodegradable tubular
element may, for example, be at least substantially
radio-transparent.
[0022] The composite prosthesis formed by the biodegradable tubular
element and the expandable annular elements may be at least
partially balloon expandable. One or more of the biodegradable
tubular element and/or at least one of the expandable annular
elements may be self-expanding. In this manner, the composite
prosthesis may be at least partially self-expanding.
[0023] Various aspects of the invention are described below with
reference to the appended figures.
[0024] FIG. 1 illustrates an embodiment of a prosthesis according
to the invention which has four sinuate expandable annular segments
covered by a biodegradable tubular element. Each of the sinuate
annular elements, a first being shown as 101, is metallic and
radiopaque while the biodegradable tubular element 102 is
radio-transparent. In the embodiment shown, each annular element is
composed of a single filament and is not connected to neighboring
annular elements by struts. Not connecting neighboring annular
elements with struts, or minimizing such connections, increases the
conformability of the device. The holes in the tubular element may,
for example, be 500 microns in diameter, as represented in the
figure, or less. The biodegradable tubular element may be polymeric
and drug loaded. The edge of the biodegradable tubular element at
each end of the prosthesis may be as shown or may, for example, be
smooth.
[0025] FIG. 2 shows a "rolled out" view of the prosthesis shown in
FIG. 1, as if the tubular prosthesis were sliced along its
longitudinal axis and flattened. The tubular prosthesis may be, but
is not necessarily, formed from flat elements as shown in FIG. 2
which are rolled into the respective annular and tubular
configurations of the prosthesis. Element 201 is the first sinuate
annular element of four such elements and element 202 is the
biodegradable tubular element of the prosthesis.
[0026] The expandable annular elements of the prostheses of the
invention may be metallic and/or polymeric in composition. Suitable
metals include, but are not limited to stainless steel, titanium,
titanium alloys, platinum and gold. Shape-memory metal alloys may
be used to produce self-expanding versions of endoprostheses
according to the invention. For example, suitable shape-memory
alloys include, but are not limited, to Nitinol and Elgiloy. The
expandable annular elements may be biodegradable or
non-biodegradable. For example, at least one or all of the
expandable annular elements may be non-biodegradable. In one
embodiment, at least one of the expandable annular elements is
biodegradable, but the biodegradable annular element(s) biodegrade
at a rate substantially slower than the rate at which the
biodegradable tubular element biodegrades. This may be achieved,
for example, by using a more slowly degrading polymer or polymer
blend for the expandable annular elements than for the
biodegradable tubular element or by making the expandable annular
elements thicker than the biodegradable tubular element such as
when both are composed of the same polymer composition.
[0027] Any type of biodegradable polymers, biodegradable polymer
blends and/or biodegradable metals or metal alloys may be used
according to the invention for the biodegradable tubular element,
and for the expandable annular elements (in embodiments in which
the annular elements are biodegradable). As used herein, the term
"biodegradable" should be construed broadly as meaning that the
polymer(s) or metal(s) will degrade, erode and/or corrode once
placed within a patient's body. Biodegradable metals include, but
are not limited to, magnesium and iron and their biodegradable
alloys, as known in the art. Biodegradable polymers as referred to
herein also include bioerodable and bioresorbable polymers.
[0028] Suitable types of biodegradable polymer materials for use in
the invention include, but are not limited to, polyester,
polyanhydride, polyamide, polyurethane, polyurea, polyether,
polysaccharide, polyamine, polyphosphate, polyphosphonate,
polysulfonate, polysulfonamide, polyphosphazene, hydrogel,
polylactide, polyglycolide, protein cell matrix, or copolymer or
polymer blend thereof.
[0029] Homopolymers of polylactic acid (PLA), for example PLLA,
PDLA and poly(D,L,)lactic acid, stereopolymers thereof, and
copolymer of PLA with other polymeric units such as glycolide
provide a number of characteristics that are useful in a polymeric
endoprosthesis for treating a lesion of a blood vessel such as a
high risk atherosclerotic plaque (vulnerable plaque). First,
polymers made of these components biodegrade in vivo into harmless
compounds. PLA is hydrolyzed into lactic acid in vivo. Second,
these polymers are well suited to balloon-mediated expansion using
a delivery catheter. Third, polymers made of these materials can be
imparted with a shape-memory so that polymeric, at least partially
self-expanding, tubular endoprostheses can be provided.
Self-expanding polymeric prostheses according to the invention may
also, for example, be at least partially balloon-expanded. Methods
for producing biodegradable, polymeric shape-memory endoprostheses
are described, for example, in U.S. Pat. Nos. 4,950,258, 5,163,952,
and 6,281,262, each of which is incorporated by reference herein in
its entirety.
[0030] Endoprostheses according to the invention may be
manufactured by any suitable method. For example, the expandable
annular elements may be produced by laser cutting the elements from
a tubular metallic blank or a tubular polymeric blank. Methods for
forming metallic and polymeric tubular blanks are well known. For
example, sputtering metallic material onto a mandrel may be used.
In another example, the shape of the expandable annular elements
can be laser cut or stamped out of a flat sheet of metallic
material and then formed and welded into a ring-like configuration.
Once formed into shape, metallic expandable annular elements may
optionally be electrochemically polished and/or etched. The
expandable annular sections may be formed separately by, for
example, laser cutting from a metallic tubular blank or by winding
a filament or band of a metallic material about a suitable
cylindrical jig. The ends of such a jig-wound expandable annular
section may, for example, be welded together to form a continuous
ring structure.
[0031] The expandable annular elements may be independent of
neighboring expandable elements, i.e., not joined to each other by
struts or other connective elements, or at least some of the
neighboring expandable elements may be joined to one another by one
or more struts and/or other connective elements, such as bands. The
connective elements referred to herein do not include the tubular
biodegradable element. For example, in embodiments in which at
least some of the neighboring annular elements are connected by one
or more struts, the struts, which may for example be segments of
filament, may be formed in the process of forming the annular
elements themselves, such as by laser cutting from a tubular blank,
or may be joined to the annular elements by welding, melting,
physical attachment or interlocking and/or by adhesive binding. In
a related embodiment, the one or more struts or other connective
elements that may connect neighboring annular elements are sized,
configured and of number to provide at least 80% open space, at
least 90% open space, or at least 95% open space in a section
between connected annular elements as measured by the area taken up
by the connective elements in the section when the prosthesis is in
its expanded state divided by the area of the wall that would be
formed by a solid tube having the same expansion radius and length
as the section.
[0032] The biodegradable tubular element may, for example, be a
continuous porous or non-porous polymeric structure or it may be a
braid, woven, or knit polymeric structure. The biodegradable
tubular element of a prosthesis according to the invention may
optionally be laser cut from a tubular blank, such as one formed by
extrusion molding. In this manner, a selected porosity and/or cell
pattern can be established in the wall of the tubular element. The
biodegradable tubular element may be at least partially
self-expanding, for example as the result of a shape-memory
characteristic. The biodegradable tubular element may, for example,
be thermoplastically expandable but not be self-expanding. The wall
of the biodegradable tubular element may be porous or non-porous.
The biodegradable tubular element may have its own radial
resiliency or its ability to remain in a radially expanded state
may rely at least predominantly on being supported or held in the
expanded state by expanded expandable annular elements of the
prosthesis.
[0033] The expandable annular elements and the biodegradable
tubular element may be attached or connected to each other in any
manner or combination of manners. In one embodiment, the expandable
annular elements and the biodegradable tubular element are attached
to each other by one or more sutures about the circumference of an
expandable annular element. In another embodiment, the expandable
annular elements and the biodegradable tubular element are attached
to each other by an adhesive at one or more points about the
circumference of an expandable annular element. In one embodiment,
the expandable annular elements and the biodegradable tubular
element are attached to each other by one or more hooks provided by
and positioned about the circumference of a expandable annular
element. For example, a hook grasping mechanism as disclosed in
U.S. Publication No. 2003/0009213 may be used. In a further
embodiment, the biodegradable tubular element and expandable
annular elements may be fixed to each other using an adhesive. The
adhesive may be biodegradable or non-biodegradable. In another
embodiment, the expandable annular elements are positioned within
the lumen of the biodegradable tubular element but are not
physically affixed to each other. When such a prosthesis
configuration is crimped onto a balloon delivery catheter and
expanded at the delivery site, the expandable annular elements
press the overlying sections of the tubular element against the
vessel wall, thereby maintaining each of the elements in its
desired position.
[0034] The wall thickness of the expandable annular elements and/or
biodegradable tubular elements of an endoprosthesis according to
the invention may, for example, be in the range of about 10 microns
to 500 microns, such as in the range of about 10 to 200 microns. In
one embodiment, the wall thickness is equal to or less than 200
microns, for example, equal to or less than 125 microns. In one
embodiment, the wall thickness is in the range of 20 microns to 125
microns. In another embodiment of the invention, the wall thickness
is in the range of 20 to 60 microns. In still another embodiment,
the wall thickness is in the range of 50 to 100 microns.
[0035] A prosthesis according to the invention may be manufactured
in any desired length. For example, a prosthesis according to the
invention may have a length in the range of 1 to 4 centimeters,
such as about 1.8 centimeters. The device may also be manufactured
with any suitable unexpanded radius and potential maximum expanded
radius, which will be determined by the radius required for
catheter delivery and the expanded radius required to bring the
wall of the device into contact with the lumen wall of a blood
vessel, such as the coronary artery.
[0036] For polymeric components of an endoprostheses according to
the invention, one or more drugs may be blended with the polymer
melt during the formation of an article and/or soak-loaded into the
article. Drugs may include, but are not limited to
anti-proliferative drugs, immunosuppressant drugs,
anti-inflammatory drugs, e.g., steroidal and non-steroidal
anti-inflammatory drugs, anti platelet drugs, anti-migratory drugs,
anti-thrombotic drugs, drugs that regress plaque, high density
lipoprotein (HDL)-mimetics, peptides, polypeptides, hormones,
cytokines, agents that promote endothelial cell growth, prohealing
drugs and combinations thereof. Drugs according to the invention
may, for example, be small molecules, peptides, polypeptides, and
radioisotopes.
[0037] As used herein the term drug means any sort of agent or
compound that has a desired therapeutic and/or prophylactic effect
and/or facilitates the role and/or acceptance of the endoprosthesis
in the body. For example, drugs may be directed to treating a
condition, such as vulnerable plaque and/or may be directed to
preventing prosthesis-induced thrombosis, such as heparin. Agents
that promote endothelial cell growth and/or reduce inflammation may
be used for the treatment of vulnerable plaque. Exemplary agents
promoting endothelial cell growth include, for example, vascular
endothelial growth factor (VEGF) and estradiols, such as
17-beta-estradiol.
[0038] Metallic or non-metallic components of endoprostheses
according to the invention may be coated with one or more polymer
coatings. The coating(s) may optionally include or be loaded with
drugs useful for treating vulnerable and/or for facilitating the
desired functioning of the implanted endoprosthesis, for example,
anti-thrombotic agents such as heparin to inhibit
endoprosthesis-induced thrombosis at the treatment site. U.S. Pat.
No. 5,624,411 teaches methods of coating intravascular stents with
drugs, and is hereby incorporated by reference in its entirety.
[0039] A further embodiment of the invention provides a method for
treating vulnerable plaque in a patient in need thereof that
includes the step of deploying any of the prostheses described
herein at the site of a vulnerable plaque lesion in the patient.
Preferably, the prosthesis is positioned so that the tubular
element at least partially covers a section of blood vessel that
has the vulnerable plaque lesion. The deployment involves an
expansion of the radius of the device to that the prosthesis comes
into contact with the vessel wall. Contact with the vessel wall
provides embolic protection and promotes re-endothelialization,
thereby passivating the vulnerable plaque. The tubular element
erodes in time and the expandable annular elements, if they are
non-biodegradable or not yet fully degraded, become disposed in the
surrounding tissue (so that they surround the blood vessel wall) or
remain in contact with the vessel wall.
[0040] The endoprosthesis may be delivered in a decreased radius
configuration on a delivery catheter. The endoprosthesis may be
crimped on or otherwise positioned around an inflatable deployment
balloon, so that expansion of the balloon at least partially
expands the endoprosthesis to its final working radius, for
example, in a coronary artery. For self-expanding versions of the
endoprosthesis, use of a delivery balloon is optional. A
self-expanding prosthesis may, for example, be restrained in a
cylindrical cavity covered by a restraining sheath and deployed by
retracting the sheath, as known in the art.
[0041] Any of the treatment methods of the invention may include a
step of locating a vulnerable plaque lesion to be treated by the
endoprosthesis in a patient.
[0042] According to the invention, determining the location of a
vulnerable plaque in a blood vessel of a patient can be performed
by any method or combination of methods. For example,
catheter-based systems and methods for diagnosing and locating
vulnerable plaques can be used, such as those employing optical
coherent tomography ("OCT") imaging, temperature sensing for
temperature differences characteristic of vulnerable plaque versus
healthy vasculature, labeling/marking vulnerable plaques with a
marker substance that preferentially labels such plaques, infrared
elastic scattering spectroscopy, and infrared Raman spectroscopy
(IR inelastic scattering spectroscopy). U.S. Publication No.
2004/0267110 discloses a suitable OCT system and is hereby
incorporated by reference herein in its entirety. Raman
spectroscopy-based methods and systems are disclosed, for example,
in: U.S. Pat. Nos. 5,293,872; 6,208,887; and 6,690,966; and in U.S.
Publication No. 2004/0073120, each of which is hereby incorporated
by reference herein in its entirety. Infrared elastic scattering
based methods and systems for detecting vulnerable plaques are
disclosed, for example, in U.S. Pat. No. 6,816,743 and U.S.
Publication No. 2004/0111016, each of which is hereby incorporated
by reference herein in its entirety. Temperature sensing based
methods and systems for detecting vulnerable plaques are disclosed,
for example, in: U.S. Pat. Nos. 6,450,971; 6,514,214; 6,575,623;
6,673,066; and 6,694,181; and in U.S. Publication No. 2002/0071474,
each of which is hereby incorporated herein in its entirety. A
method and system for detecting and localizing vulnerable plaques
based on the detection of biomarkers is disclosed in U.S. Pat. No.
6,860,851, which is hereby incorporated by reference herein in its
entirety. Angiography using a radiopaque and/or fluorescent dye,
for example, as known in the art, may be performed before, during
and/or after the step of determining the location of the vulnerable
plaque, for example, to assist in positioning the prosthesis in a
subject artery.
[0043] Although the foregoing description is directed to the
preferred embodiments of the invention, it is noted that other
variations and modifications will be apparent to those skilled in
the art, and may be made without departing from the spirit or scope
of the invention. Moreover, features described in connection with
one embodiment of the invention may be used in conjunction with
other embodiments, even if not explicitly stated above.
* * * * *